PIL - Escitalopram 5mg, 10mg, 20mg Film coated Tablets: Change history
View Patient Information Leaflet (PIL - Escitalopram 5mg, 10mg, 20mg Film coated Tablets)
Last updated on this site: 12 May 2025
The following change(s) has been notified:
Type IA in B.II.b.1 Substitution or addition of a manufacturing site for part or all of the manufacturing process of the finished product
a) Secondary conditioning site
"Addition of the manufacturer Accord Healthcare Single Member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece, as an alternative site responsible for secondary packaging of the finished product."
Type IA in B.II.b.2 Change in importer, batch release measures and quality control testing of the finished product
c.2) Replacement or addition of a manufacturer responsible for batch release. Including batch control or testing
"Addition of the manufacturer Accord Healthcare Single Member S.A., 64th Km National Road Athens Lamia, Schimatari, 32009, Greece, as an alternative site responsible for batch release including batch control/testing of the finished product."
Last updated on this site: 12 May 2025
The following change(s) has been notified:
Type IA in B.II.b.1 Substitution or addition of a manufacturing site for part or all of the manufacturing process of the finished product
a) Secondary conditioning site
"Addition of the manufacturer Accord Healthcare Single Member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece, as an alternative site responsible for secondary packaging of the finished product."
Type IA in B.II.b.2 Change in importer, batch release measures and quality control testing of the finished product
c.2) Replacement or addition of a manufacturer responsible for batch release. Including batch control or testing
"Addition of the manufacturer Accord Healthcare Single Member S.A., 64th Km National Road Athens Lamia, Schimatari, 32009, Greece, as an alternative site responsible for batch release including batch control/testing of the finished product."
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Changes: (Updated: 12 May 2025)
The following change(s) has been notified:
Type IA in B.II.b.1 Substitution or addition of a manufacturing site for part or all of the manufacturing process of the finished product
a) Secondary conditioning site
"Addition of the manufacturer Accord Healthcare Single Member S.A., 64th Km National Road Athens, Lamia, Schimatari, 32009, Greece, as an alternative site responsible for secondary packaging of the finished product."
Type IA in B.II.b.2 Change in importer, batch release measures and quality control testing of the finished product
c.2) Replacement or addition of a manufacturer responsible for batch release. Including batch control or testing
"Addition of the manufacturer Accord Healthcare Single Member S.A., 64th Km National Road Athens Lamia, Schimatari, 32009, Greece, as an alternative site responsible for batch release including batch control/testing of the finished product."
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Changes: (Updated: 01 Sep 2023)
Updated to bring in line with the reference medicinal product, Cipralex®. The MAH has taken the opportunity to amend editorial and QRD template changes.
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Changes: (Updated: 30 May 2023)
Updated to bring in line with the reference medicinal product, Cipralex®. The MAH has taken the opportunity to amend editorial and QRD template changes.
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Changes: (Updated: 20 Sep 2022)
Initial upload